ing TKA from the IPO list, asserting that performing TKA in the outpa-
tient setting is not clinically appropriate for the Medicare population
because Medicare beneficiaries are more likely to have comorbidities
not experienced by typically younger non-Medicare patients. These
commenters expressed concern that because of such comorbidities,
Medicare beneficiaries face increased complications, recovery times
and rehabilitation needs as compared to non-Medicare populations. In
response, CMS emphasized that its decision permits, but does not
require, TKA to be performed in the outpatient setting. CMS further
stated that it expects physicians to continue to exercise appropriate
medical judgment in selecting the TKA setting for each patient. Such
judgement will likely depend on a number of factors, including the
patient's comorbidities, the expected length of stay in the hospital and
the patient's anticipated need for postoperative skilled nursing care.
• Patient selection. CMS declined to establish specific guidelines or
content for patient selection protocols, stating instead that "the deci-
sion regarding the most appropriate care setting for a given surgical
procedure is a complex medical judgment made by the physician
based on the beneficiary's individual clinical needs and preferences
and on the general coverage rules requiring that any procedure be rea-
sonable and necessary." According to CMS, at least 2 orthopedic spe-
cialty associations submitted comments indicating that their organiza-
tions were in the process of developing evidence-based inpatient and
outpatient selection protocols for TKA.
• Two-midnight rule. Now that TKA is no longer on the IPO list, it
will be subject to the "two-midnight rule," which considers an inpatient
admission medically necessary and appropriate if the physician
expects the beneficiary to require hospital care that spans at least 2
midnights. If the physician expects the patient to require hospital care
not spanning 2 midnights, an inpatient admission may still be payable
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